Male Telescope Catheter

ABSTRACT

A catheter includes a proximal section that is inserted into and telescopically movable relative to a distal section. A proximal end of the proximal section is insertable into a urethra of a user and the distal section provides a discharge conduit for urine. The proximal section includes a rear portion, and an exterior surface of the rear portion diverges away from the proximal end to provide a diverging rear transition section that is wider than the proximal end of the proximal section. The distal section includes a front portion and an interior surface of the front portion converges to an opening formed in a front transition end, the opening is narrower than the diverging rear transition section of the proximal section.

FIELD OF THE INVENTION

The present invention relates to a catheter, especially an expandablecatheter with a transition between the individual sections allowinginsertion of the transition into urethra.

BACKGROUND

A certain flexibility of a catheter is needed to pass through thecurvature of the urethra. Normally a catheter is made of the same,flexible, material all the way through. When reaching some resistancewhen pushed through the urethra, the part of the flexible tube not yetinserted tend to bend. The user will often touch the catheter tube byhand to aid insertion; thereby increasing the risk of urinary tractinfections.

It is also a commercial reality that male catheters take up more spacethan convenient to the user, either at home or on the road.

To comply with the desire for less space consuming catheters, especiallycatheters having a collapsible, or otherwise space reducing, insertablepart is needed. Different types of telescopic catheters have furthermorebeen disclosed in the art.

U.S. Pat. No. 6,592,567 disclose a kidney perfusion catheter assemblyhaving an introducer catheter and a catheter tip. The catheter tip movescoaxially in the distal end of the introducer catheter. The tip may beretracted within the introducer catheter or telescopically extended fromthe distal end of the introducer catheter component.

U.S. Pat. No. 4,632,668 discloses an extendable/retractable ventricularcatheter which is essentially a two-piece telescoping assembly with adistal catheter slideably extending from within a proximal catheter.When the distal catheter is extended to its maximum length from withinthe proximal catheter, the two pieces are prevented from coming apart bythe distal catheter having an external locking means and the proximalcatheter having internal locking means.

However, urinary catheters must be extended before insertion and therebyneeds to be locked in such a way that the catheter to do not collapseduring insertion. WO 03/002179-A2 discloses a kit for preparing acatheter for draining a human bladder, the kit comprising at least twocatheter sections defining a passage therein, the sections being adaptedto be arranged in such a mutual configuration that the passages arejoined into one passage and the sections together constitute a catheterof a length larger than the length of each individual section and havingsuch rigidity that the entire catheter can be manipulated bymanipulation of one of the sections individually. In particular, WO03/002179-A2 is concerned with a catheter in which a first section isinsertable into the urethra and a second separate section is suitablefor external manipulation.

DETAILED DISCLOSURE

It is an object of the invention to provide a collapsible catheter witha relatively long insertable length. Accordingly, the invention, in afirst aspect, provides a catheter which is operable between a collapsedconfiguration for storage and transportation and an expandedconfiguration for draining fluid from a body via a conduit which extendsaxially in a longitudinal direction from a proximal end to an oppositedistal end, the catheter comprising: a proximal section, adapted to befully inserted into a urinary channel of the body and forming a proximalpart of the conduit which part extends axially between the proximal endand a first transition end of the proximal section, and a distalsection, adapted to be at least partially inserted into the urinarychannel and forming a distal part of the conduit which part extendsaxially between a second transition end of the distal section and thedistal end, an insertable part of the first transition end beingdimensioned to enable its positioning inside a receiving portion of thedistal part of the conduit to enable axial movement of the sectionsrelative to each other to operate the catheter between the collapsedconfiguration and the expanded configuration of the catheter, whereinthe sections comprise cooperating coupling structures to support thecatheter in the expanded configuration.

This allows for an expandable catheter where the insertable catheterpart, i.e. both the proximal section and the distal section, istelescopically retractable and expandable between a collapsedconfiguration and an expanded configuration. The catheter advantageouslyconsumes less space in the collapsed configuration than in the expandedconfiguration. Thus, a catheter is provided which takes up less spacewhen stored or transported in its collapsed configuration. This allowsfor reduced space consumption during transport and also for improvedlife quality for the user of catheter as such expandable catheters canbe stored more discreetly.

The term collapsed configuration of the catheter according to theinvention should be understood broadly as any configuration where theaxial extent of the catheter is smaller than the expanded configurationwherein the coupling structures of the distal section and proximalsection couples the catheter into an expanded configuration. By couplingis understood that it requires a larger force to move the catheter fromthe expanded configuration to the collapsed configuration than to movethe catheter oppositely from the collapsed configuration to the expandedconfiguration.

Furthermore, a catheter where the insertable part is collapsible isespecially advantageous for male users, as their urethra is considerablylonger compared to urethra of female users. However, the presentinvention may also be used for the insertable part of a female catheter.

During use, the catheter is brought to the expanded configuration andthe proximal end is guided into the urethra. Subsequently, the sectionsare inserted until urine starts to flow through the conduit.

In one embodiment the sections are provided so that a first longitudinaldirected force required for moving the catheter from the expandedconfiguration to the collapsed configuration is larger than a secondlongitudinal directed force required for at least one of the proximalsection and the distal section to bend.

The coupling may e.g. be rigid enough to enable insertion and optionallycurling up of the catheter in a container, without moving the catheterto the collapsed configuration. This may also increase the safetyagainst collapsing of the catheter during insertion of the sections intothe urethra. The push-in force required to insert the catheter into theurethra is approximately 1 N. In one example, the catheter couplingresists a force in the range of 5-10 N, and the same catheter bends outor kink at a longitudinal force in the range of 2-3N. I.e. the catheterbends or kink prior to the release of the coupling, and to move thecatheter to the collapsed state, the sections must be manipulated from aposition very close to the transition ends of the sections. As anexample, the catheter could be made so that it can only be moved to theexpanded configuration and so that attempts to move it back destroys thecatheter and thus makes it unusable for further use.

In an alternatively embodiment the sections are provided so that a firstlongitudinal directed force required for moving the catheter from theexpanded configuration to the collapsed configuration is smaller than asecond longitudinal directed force required for at least one of theproximal section and the distal section to bend.

This provides for an expandable catheter, which can be easily collapsedafter use in a controlled fashion as it will collapse into its collapsedconfiguration wherein it can be contained until disposal. In thisembodiment, it is desirable that the force which is required to collapsethe catheter is higher than the force required to insert the catheterinto the urethra. I.e. the coupling is sufficiently strong to maintainthe expanded configuration during the bending of the catheter as entersthrough the curved passage of the urethra, in particular of mail users.After use, when the catheter is removed from the urethra, the couplingshould, on the contrary, allow collapsing of the catheter by pushing thetwo sections towards each other, and the movement towards the collapsedconfiguration should preferably take place prior to kinking of thecatheter.

In one embodiment the proximal section forms a first outer surface witha circumference which increases from the proximal end towards the firsttransition end and/or the distal section forms a second inner surfacewith a circumference which decreases from the distal end towards thesecond transition end. In particular, the distal section may decrease toa circumference which is smaller than the circumference of thetransition end of the proximal section. This provides a simple stopwhereby the distal section and the proximal section may not be pulledapart when the catheter is in the expanded configuration.

In order to provide a smooth fit or alternatively simple couplingstructures the first outer surface may form a first angle to thelongitudinal direction, and the second inner surface may form a secondangle to the longitudinal direction, the first angle being at least ofthe size of the second angle. When the angles are the same size, theinner surface of the distal section and the outer surface of theproximal section may join in parallel planes, and when the first angleis larger than the second angle, the surfaces may join by a slightdeformation when the two sections are pulled tightly towards theexpanded configuration. Accordingly, the transition ends of the sectionsor at least the transition end of one of the sections may preferably bedeformable by pulling the sections towards the expanded configuration byhand.

To facilitate the coupling of the sections, one of the proximal anddistal sections may comprise a protrusion cooperating in the expandedconfiguration with a depression of the other one of the proximal anddistal sections. This provides easy produced coupling structures whichallow the distal and proximal section to engage and thereby to lock thecatheter in the expanded configuration.

The depression may form a circumferentially extending slot in an outersurface of the section in question. The slot may for example be providedin an outer surface of the proximal section. The slot may have anycross-sectional shape. However, a relatively sharp edged shape, e.g. aV-shape or a U-shape when seen in a longitudinal cross-section may serveto retain the protrusion. In particular, the protrusion may have a.shape which is similar to the shape of the slot.

The outer surface and the inner surface of both the proximal section andthe distal section may have different shapes, be formed with a number oflocal shapes, such as corresponding protrusions and indents, or moregeneral shapes covering larger areas, such as sloping faces etc. Suchshapes and forms may be provided in order to provide differentfunctions, for example coupling structures or improved sliding surfaces.

Although such coupling structures typically will be formed ascircumferentially extending shapes and formations having a continuouscircumference in order to provide sealing means, they may also beprovided as local bulges or the like having limited extent in alldirections.

In one embodiment of the catheter according to the invention the distalsection comprises an inner surface portion which forms a part of a wallof the conduit in the second transition end, which inner surface portionforms a distance, a, to a centre axis, and the proximal sectioncomprises an outer surface portion being adjacent to the insertablepart, which outer surface portion forms a distance, b, to the centreaxis, wherein b is larger than a.

In the present invention catheters are typically formed of tubes havinga circular cross section. A change in the dimensions of differentsurface portions of the tube, i.e. the distance from the tubes centreaxis to the corresponding surface portions, will correspond to the tubesradius or diameter in that respective portion. However, when the tube isdeformed or catheters having different cross sectional shapes are usedthe term radius, diameter or distance from the surface portion to thecentre axis may not always be unambiguously used. Alternatively it canbe said, that the respective surface portions may have differentcircumferences to indicate a change in the surface corresponding to achange of the radius or diameter of a tube having a circular crosssection.

In order to thereby provide a protruding rim, an upwardly slopingsurface the proximal section may thus comprises an outer surface with afirst surface portion with a first circumference which first surfaceportion, in the longitudinal direction, is followed by a second surfaceportion with a second circumference which is larger than the firstcircumference.

Additionally in order to for example forming above mentioned slot thesecond surface portion, in the longitudinal direction is followed by athird surface portion forming the slot and having a third circumferencebeing smaller than the second circumference.

To completely define the slot, the slot can be followed by a fourthsurface portion with a fourth circumference being larger than thecircumference(s) of the third surface portion.

In order to support the position of the proximal section relative to thedistal section the protrusion may form a circumferentially extending keyadapted to cooperate with the slot in the expanded configuration.

In one embodiment the key forms a fifth surface portion which protrudesfrom an inner surface of the distal section. Additionally the fifthsurface portion may have a circumference which is smaller than thecircumference of the remaining inner surface of the distal section.

In one embodiment, in order for the key and slot to couple, the fifthsurface portion has a circumference which is smaller than thecircumferences of the second and fourth surface portions.

In another embodiment of the catheter according to the invention a gapis formed between the third surface portion and the fifth surfaceportion in the expanded configuration and/or between the first surfaceportion and the fifth surface portion in the collapsed configuration.Advantageously such a gap prevents that the fifth portion, typicallydefined by the key, scrapes against the first and third second surfaceportions. In particular this is advantageous when the catheter ishydrophilic coated whereby it is avoided that the third surface scrapesof the coating when the gap contains a hydrophilic fluid, a hydrogel orother type of fluid coating.

It has furthermore surprisingly shown that the hydrophilic coating, oralternatively gel coating, function as suspension mean between the fifthsurface portion and the first and third surface portion respectively. Inother words, the coating suspends the fifth surface around the first orfifth surface portion respectively evenly providing an evenly disposedgap around the corresponding circumference.

Furthermore, especially when using gel coated catheters, the key mayadvantageously function as distributor, to evenly distribute the gelaround the proximal section when the catheter is moved from itscollapsed position to its expanded position.

In order to further reduce the risk of scraping off the hydrophiliccoating and to protect the mucosa, at least the transition ends of thesections are circular in a cross-section perpendicular to thelongitudinal direction, thereby create a smooth transition.

It should be understood that the proximal section and the distalsections do not necessarily needs to be formed of one single element.Due to for example production limits, production costs, materialcharacteristics etc, the individual elements can be made of a number ofseparate parts.

Thus, in one embodiment of the catheter according to the invention theproximal section comprises: a tubular member forming the proximal end ofthe catheter, and a sleeve with an outer surface with a sixth surfaceportion and a seventh surface portion, the circumference of the sixthsurface portion being larger than the circumference of the seventhsurface portion, the sleeve being inserted into a conduit so that theseventh surface portion is in contact with an inner surface of thetubular member and the sixth surface portion forms an outer surface ofthe proximal section.

Alternatively the sixth surface portion has a larger circumference thanthe outer surface of the tubular member, which provides a raised area,for example a rim, on the proximal section.

The seventh surface portion may furthermore comprise an enlarged surfaceportion in which the circumference is larger than in the remaining partof the seventh surface portion. This advantageously provides improvedmeans for holding the sleeve and tubular member assembled.

Additionally a material of the tubular member and a size of the enlargedsurface portion may be chosen so that the enlarged surface portiondeforms the outer surface of the tubular member and forms a protrusionon that surface. This provides a curved bulb on the outer surface of thetubular member. Furthermore, by providing a rim between the sixthsurface portion and the tubular member as mentioned above, a slot asdescribed earlier may be provided.

Likewise may the distal section also comprise of different members. Forexample in one embodiment the distal section comprises: a tubular memberforming the distal end of the catheter, and a sleeve with an outersurface with a eighth surface portion and a ninth surface portion, thecircumference of the eighth surface portion being larger than thecircumference of the ninth surface portion, the sleeve being insertedinto a conduit so that the ninth surface portion is in contact with aninner surface of the tubular member and the eighth surface portion formsan outer surface of the proximal section. The sleeve may thus partlyfunction as a support member, where the ninth surface portion providesimproved support for the tubular member. Furthermore, a part of thesleeve will extend inwards from the ninth surface portion and therebyforms a key, which may engage with a respective slot on a proximalsection as described earlier.

In order to provide a smooth transition between the proximal section andthe distal section when the catheter is in the expanded configuration,the sleeve may form the second transition end of the distal section andwherein the eighth surface portion has a circumference which decreasestowards the second transition end.

Within the scope of the invention many different embodiments andalternative solutions may be provided.

Thus, the present invention may also relate to an expandable cathetercomprising a proximal section and a distal section, both sectionsforming a part of a conduit,

-   the proximal section comprising an insertion end for insertion into    an opening with an aperture for draining a fluid into the conduit,    the conduit extending towards an opposite transition end, the    proximal section having an outer circumference which increases (A)    towards the transition end, and-   the distal section comprising a transition end receiving fluid from    the transition end of the proximal section into the conduit when the    catheter is expanded, the conduit extending toward an opposite    guiding end, the distal section having an outer circumference which    decreases towards a transition end, the transition end of the    proximal section being dimensioned to enable its positioning inside    the conduit of the distal section to enable movement of the sections    relative to each other.

An inserted surface coated catheter is pulled out of location in theurethra with a force of about 0.2 N. For an uncoated catheter, thispull-out force is in the range of 2 N. It is much preferred that thetransition between the two sections of the catheter is constructed suchthat the transition will endure the pull-out force. Otherwise, thecatheter could separate into two pieces and the proximal section remainin the urethra.

Typically, the force required to insert a catheter, the push-in force,is about 1 N for a coated catheter. Thus, it is much preferred that thetransition between the two sections of the catheter is constructed suchthat the transition will endure the push-in force.

Otherwise, the catheter could collapse into the non-expanded stateduring insertion. As a rule of thumb, the ability to endure the push-inforce must be so that the catheter will tend to bend when exposed tohigh push-in forces, before it will tend to collapse into thenon-expanded state. It is our experience that forces of more than 10 Nare not required to insert a catheter.

In one embodiment the elasticity of the transition end of the proximalsection is less than the elasticity of the remaining part of theproximal section. With a lower elasticity is understood that this partof the proximal section is less flexible, less bendable, and lesscompressible than the remaining part of the proximal section.

In one embodiment the elasticity of the transition end of the distalsection is lower than the elasticity of the remaining part of the distalsection. In a related embodiment, the transition end of the distalsection, with a lower elasticity, is followed by (moving towards theproximal end) a segment constituting the tip of the distal transitionpart.

As E-modulus is a constant describing the material, a simple way ofobtaining a segment with decreased elasticity is to increase the wallthickness. However, the same can be obtained by using another materialwith high e-modulus.

In one embodiment, the outer circumference of the transition end of theproximal section is larger than the inner circumference of thetransition end of the distal section. By this arrangement is achievedendurance during the pull-out force. However, in order to make sure thatthe transition end of the proximal section can be positioned inside theconduit of the distal section and to enable movement of the sectionsrelative to each other, the outer circumference of the transition end ofthe proximal section is preferably less than the inner circumference(the conduit circumference) of the distal section. This is one exampleof how the proximal section can be adapted to be displaceable arrangedwithin the distal section.

In one embodiment, the transition end of the distal section and thetransition end of the proximal section of the catheter are conicallyshaped. When drawn together during expansion of the telescopic catheter,the two conically shaped transition ends will grab and lock each other.The grab and lock is affected by:

-   -   the angle between the longitudinal direction of the catheter and        the conical erection (see Error! Reference source not        found., (7) and (8)). An acute angle (less than 90°) will secure        locking between the two sections. The more pointed, the better        the lock between the two sections. Thus, the angle is preferably        less than 40°. Due to the tubular dimensional restrictions, such        acute angle will optimize the length of material in contact with        each other and thereby increase the frictional force obtained.    -   the deformation of the materials. The higher the E-modulus of        each of the two sections, the less the material will deform        during the expansion, and it will be harder to separate the        sections after the transition ends have grabbed and locked each        other during expansion of the telescopic catheter.    -   thickness of the materials. It is preferred that the thickness        of the distal section is as thin as possible, so the transition        is as small as possible. Preferably the distal section is 0.35        mm in wall thickness. The proximal section is preferably between        0.4 and 1 mm in wall thickness.

In one embodiment a third element is attached to at least one of theconical surfaces. This third element can indirectly modulate theelasticity of the transition ends, allowing a secure grab and lock,without compromising the aforementioned requirements.

When in use, the catheter is expanded by pulling the two sections inopposite directions and secured. That is, the conical shape of thedistal section is deformed (expanded) when the conical shape of theproximal section is inserted. Likewise, the conical shape of theproximal section is deformed (compressed) when the conical shape of thedistal section is draw over it. The grab and lock features will secureendurance during both the pull-in force and the push-out force, and theproximal transition end is wedged inside the distal transition end whenthe catheter is fully expanded. This set of embodiments is especiallypreferred for catheters without coating, that is for catheters were asubstantial friction force is generated between the distal- and proximalsections.

However, for coated catheters, typically with a friction coefficient (μ)around 0.05, the friction force generated during use will not besufficient to hold the sections together so they that do not collapseduring insertion, and/or to prevent them from separating.

In the conical contact zone, at the interface between the transitionends of the proximal and distal sections—if for simplicity looking at across section—the resulting force acting between them—can be dividedinto a normal force F_(N) (perpendicular to the contact surface) and afriction force F_(f) (tangential to the contact surface). If consideringCoulomb friction, the relation between the friction force and the normalforce can be described by; F_(f)=μ·F_(N) where μ is the frictioncoefficient.

In dry conditions the friction coefficient will be high (e.g. forpolyurethane expectedly at least μ=0.5 and probably even higher than 1).As a result the friction force will be comparable to the normalforce—and as a consequence the force to separate the proximal and distalsections will be high—even for small conical angles α (where thefriction force is close to parallel to the separation force acting alongthe longitudinal axis of the catheter). For simplicity this can beillustrated by considering one embodiment in cross section (where α₁(7)=α₂ (8)). Here the separation force can be described by thehorizontal components of the sum of the normal force and the frictionforce (referring to FIG. 15):

Separation  force(F_(sep)) = cos (α) ⋅ F_(f) + sin (α) ⋅ F_(N) = cos (α) ⋅ μ ⋅ F_(N) + sin (α) ⋅ F_(N) = (cos (α) ⋅ μ + sin (α)) ⋅ F_(N)

As seen from this equation—if μ is close to 0—a high separation forcecan only be obtained either by:

a. having an angle α close to 90 deg, orb. by ensuring that very high normal forces F_(n) can be sustained byboth the distal and proximal sections in contact.

In one embodiment of the invention, the angle α is over 70°, such asbetween 70° and 90°, between 80° and 90° or even between 85° and 90°. Inthese embodiments, the shape of the proximal section, is a T-shape.

In one embodiment of the invention, the angle α is over 90°, such asbetween 90° and 130°.

In one embodiment, the distal transition part and the proximaltransition parts are secured by mechanical means. One such example iswherein an element passes a bulb allowing passage in one direction butnot in the other. One such example is disclosed in Example 4. This isespecially preferred along with catheters with and angle α of about 90°,as that angle will secure endurance during the pull-out, whereas a bulbwill secure endurance during the push-in. In one embodiment the bulb isplaced on the outside of the proximal section. This bulb will also havethe function to aid in providing a smooth transition. In anotherembodiment, the bulb is placed on the inside of the distal section. Inthe embodiment where the catheter is coated, the bulb on the outsidemight be left without coating when the catheter is ready for use and thetip of the distal section has passed the bulb. Thus, in a preferredembodiment, the bulb is placed on the inside of the distal section. Toobtain maximal endurance during push-in, a bulb is placed on bothsections.

Another such example is applying one end of a plurality of hairs toeither, or both, transition parts. On the proximal part the other end ofthose hairs are left pointing distally. On the distal part the other endof those hairs are left pointing proximally. Hereby, the sections willslide smoothly across each other (running along the direction of thehairs), but will experience substantially higher resistance sliding theother way (against the direction of the hairs).

The mucosal inside of the urethra comprises a number of folds in thelongitudinal direction, along with normal urine flow. These mucosalfolds are sensitive to sharp or pointed parts of a catheter that willdamage the mucosa causing pain and bleeding. It is therefore preferredthat the exterior of the transition between the two sections of thecatheter according to the invention is smooth. Smooth, in this contextis intended to mean that it is smooth enough not to damage the mucosa.Especially, the actual point of transition, that is where mucosalexposure to the proximal section stops and mucosal exposure to thedistal section begins. Such smoothness is obtained in one of the waysdescribed below, or a combination thereof:

-   -   the tip of the distal transition part is rounded, such that no        sharp edges are present.    -   the point where the distal section goes from a tube to a conical        shape is rounded, such that no sharp edges are present.        Alternative shapes are concave, convex and straight.    -   eliminating the gap (0.15 to 0.2 mm in radius) between the        proximal and distal sections, at the transition end. This can be        done by increasing the diameter of the proximal section locally        at the transition end to obtain a close fit with the hole in the        distal end of the distal section (see FIG. 15).    -   a bulb is provided on the outer surface of the proximal tube,        just proximally to the transition section. This bulb will ‘lift’        the mucosa to avoid contact with the point of transition.        Furthermore, such bulb will act as a mechanical lock between the        distal and the proximal section of the catheter allowing passage        in one direction but not in the other.    -   the thickness of the distal transition section is decreased to a        thin foil of between 0.02 mm to 0.1 mm. preferably between 0.05        to 0.1 mm. The less thickness of this distal transition section,        the less the difference in the point of transition.

In one embodiment of the invention the catheter is coated to provide aslippery surface for easy insertion. In order to prevent that thiscoating is damaged during extension of the catheter, it is preferredthat the open hole in the tip in the transition end of the distalsection is slightly bigger, such as 0.15 mm bigger, or 0.2 mm bigger,than the outer diameter of the tube in the proximal section. Therebytouching of surface by the tip is limited.

In one embodiment the elasticity of the distal section is different fromthe elasticity of the proximal section, thereby controlling whichsection is deformed when a force is applied. The proximal sectionpreferably has an elasticity comparable to that known from commoncatheters, to allow passage through urethra, prostate and sphincter. Thedistal section preferably has a lower elasticity than the proximalsection, this is needed not to bend during insertion, withstanding thepush-force.

It is preferred that the proximal section is of the thickness commonlyused for catheters, that a wall thickness is between 0.4 mm and 1 mm. Itis preferred that the distal section is about 0.35 mm.

It is preferred that each of the two sections are between 70 and 230 mmThe expanded catheter will have a total length of between 250 mm and 360mm.

It is preferred that the proximal section has a length between 150 mmand 230 mm. This allows the proximal section to be inserted throughurethra, and the transition to the distal section being close toinsertion (or just inserted) such that the distal section with the highe-modulus (and more stiff part) will withstand the slightly higher forceneeded to insert the catheter through prostate and sphincter. The distalsection is preferably with a length between 100 mm and 130 mm.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a first embodiment of an expandable catheter according tothe invention seen in cross section along a longitudinal axis,

FIG. 2 shows a chart indicating the force required to pull apart toconically shaped transition sections and where the ordinate axisindicates max load [N],

FIG. 3 shows a second embodiment of the catheter according to theinvention seen in cross section along a longitudinal axis,

FIG. 4 shows a third embodiment of the catheter according to theinvention seen in cross section along a longitudinal axis,

FIG. 5 shows a fourth embodiment of the catheter according to theinvention seen in cross section along a longitudinal axis,

FIG. 6 shows a fifth embodiment of the catheter according to theinvention seen in cross section along a longitudinal axis,

FIG. 7 shows a sixth embodiment of the catheter according to theinvention seen in cross section along a longitudinal axis,

FIG. 8 shows a seventh embodiment of the catheter according to theinvention seen in cross section along a longitudinal axis,

FIG. 9 shows seen in section an eighth embodiment of the catheteraccording to the invention,

FIG. 10 shows seen in section a ninth embodiment of the catheteraccording to the invention,

FIG. 11 shows seen in section a tenth embodiment of the catheteraccording to the invention,

FIG. 12 shows a chart of the results of a tensile test performed on adistal section of a catheter according to the invention,

FIG. 13 shows a chart of the results of a tensile test performed on aproximal section of a catheter according to the invention,

FIG. 14 shows an eleventh embodiment of the catheter according to theinvention seen in cross section along a longitudinal axis,

FIG. 15 shows schematically forces exerted on an embodiment of thecatheter according to the invention,

FIG. 16-21 shows a twelfth embodiment of the catheter according to theinvention, and

FIG. 22 shows a thirteenth embodiment of the catheter according to theinvention seen in cross section along a longitudinal axis.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

In the following, preferred embodiments of the invention will bedescribed in further details with reference to the drawing in which FIG.1 shows a telescopic catheter, with a distal 1 and a proximal section 2.The distal section 1 has a transition end 3 and a proximal guiding end4. The proximal section 2 has a transition end 5 and a distal insertionend 6. The angle between the longitudinal direction of the catheter andthe conical erection on the distal section is marked 7. The anglebetween the longitudinal direction of the catheter and the conicalerection on the proximal section is marked 8. The transition end of theproximal section has an outer diameter which is higher than theremainder of the proximal section (the difference A). The transition endof the distal section has on outer diameter which is smaller than theremainder of the proximal section (the difference B).

FIG. 3 shows the principle of another embodiment of a catheter 30according to the invention. The distal section 1 (the outer section)displays a decreased outer circumference 31 in the transition, whereasthe proximal section 2 (the inner section) displays an increased outercircumference 32 in the transition.

The proximal end of the distal section 33 is here cut to allow for asmooth transition point.

By adding cylindrical parts such as the decreased outer circumference 31and the increased outer circumference 32 the surface of the transitionsections is increased, thereby creating a larger area wherein the distalsection and proximal section can couple together.

FIG. 4 shows another embodiment 40 of the catheter, which discloses oneway to obtain decreased elasticity in the transition end (the distalend) of the proximal section.

The embodiment of FIG. 4 is identically to the embodiment of FIG. 3,however, the thickness of the wall has been doubled by insertion of anadditional tube 41, which stabilizes the transition and providesdecreased elasticity.

FIG. 5 shows another embodiment 50 of the catheter, which discloses oneway to obtain decreased elasticity in the transition end (the distalend) of the proximal section. Here, the thickness of the end wall of thedistal section 1 has been increased by molding the tube with a thickerwall 52.

FIG. 6 shows another embodiment 60 of the catheter, which discloses oneway to obtain decreased elasticity in the transition end (the proximalend) of the distal section. Here, the thickness of the end wall of thedistal section 1 has been increased by molding the tube with a thickerwall 61 on that part.

FIG. 7 shows another embodiment 70 of the catheter, which discloses acombination of FIG. 4 shows another embodiment 40 of the catheter, whichdiscloses one way to obtain decreased elasticity in the transition end(the distal end) of the proximal section.

The embodiment of FIG. 4 is identically to the embodiment of FIG. 3,however, the thickness of the wall has been doubled by insertion of anadditional tube 41, which stabilizes the transition and providesdecreased elasticity.

and FIG. 5 shows another embodiment 50 of the catheter, which disclosesone way to obtain decreased elasticity in the transition end (the distalend) of the proximal section. Here, the thickness of the end wall of thedistal section 1 has been increased by molding the tube with a thickerwall 52.

: an increased wall-thickness in the transition end of both the distalsection and the proximal section.

FIG. 8 shows another embodiment 80 of the catheter, which disclosestransition with a third element. That is, the thick black line is thedistal section 81. The outer circumference of the distal sectiondecreases (going from left to right), is followed by a flat segment, andis thereafter pointed to provide for a smooth transition point. Theproximal section 82 is the hatched line. The outer circumference of thisproximal section increases (going from right to left). The two sectionscan be pulled together. However, a third element 83 is positionedbetween the decrease in outer circumference of the distal section andthe increase in outer diameter of the proximal section.

FIG. 9 illustrates another embodiment 90 of the catheter and thetransition between the distal section 1 (left) and the proximal section2 (right). The distal section is cut to be pointed towards the end (theproximal end) and fits towards the regular tubular part of the proximalsection.

FIG. 10 illustrates another embodiment 100 of the catheter, whichdiscloses the transition between the distal section 101 (left) and theproximal section 102 (right). The distal section is cut to be pointedtowards the end (the proximal end) and fits towards the part of theproximal section undergoing an increase in outer circumference. Theinner circumference of the tip in the transition end of the distal partis bigger than the outer circumference of the proximal section so that acoating on the proximal section is not damaged when the tip passes thissection during expansion of the catheter.

FIG. 11 illustrates another embodiment 110 of the catheter, whichdiscloses a bulb 111 on the proximal tube, just proximally to thetransition part.

FIG. 14 illustrates another embodiment 140 of the catheter according tothe invention. Here a third element 141 is placed on the outside of thetransition part of the distal section. The third element is formed as aring having an outer circumference of the same size as the outercircumference of the distal section. The third element has a proximalface which tapers with the same angle as the proximal end of the distalsection.

FIG. 15 illustrates the forces between the distal section 1 and theproximal section as described earlier when the catheter is in itsexpanded configuration. The sections are only shown schematically andsolid lines indicate their walls. The area between the tapering part ofthe two sections defines the conical contact zone 150.

Although dry catheters easier engage in a frictional lock with eachother, hydrophilic catheter may also engage into a frictional lock whenfirst and second conical faces 151,152 of the two sections are pulledagainst each other in the contact zone 150. High friction may thus beprovided when a first angle α₁ of the first conical face 151 to the axisof the distal section and when a second angle α₂ of the second conicalface 151 of the axis of the proximal section is less than 40°.

Low friction is created when the first angle α₁ and the second angle α₂are between 90° and 110°.

FIGS. 16-21 shows one embodiment of an expandable catheter 151. FIG. 18shows an enlarged view of section XVIII in FIG. 17 and FIGS. 20 and 21shows enlarged views of sections XX and XXI, respectively, in FIG. 18.FIGS. 19 a and 19 b shows respectively a distal section and a proximalsection of FIG. 18. The sections illustrated in FIGS. 19 a and 19 b areshown in an exploded view along axis A-A.

The catheter 151 is operable between a collapsed configuration, shown inFIG. 16, for storage and transportation and an expanded configuration,shown in FIG. 17, for draining fluid from a body via a conduit 153 whichextends axially in a longitudinal direction, indicated by arrow 179,from a proximal end 165 to an opposite distal end 171.

The catheter comprises a proximal section 2, adapted to be fullyinserted into a urinary channel of the body (not shown) and forming aproximal part of the conduit which part extends axially between theproximal end 165 and a first transition end 164 of the proximal section2.

The catheter further comprises a distal section 1, adapted to be atleast partially inserted into the urinary channel (not shown) andforming a distal part of the conduit which part extends axially betweena second transition end 170 of the distal section 1 and the distal end171.

The first transition end 164 is dimensioned to enable its positioninginside a receiving portion of the distal part of the conduit 153 toenable axial movement of the sections relative to each other to operatethe catheter 151 between the collapsed configuration and the expandedconfiguration of the catheter, wherein the sections comprise cooperatingcoupling structures to support the catheter in the expandedconfiguration.

Beside the proximal section 2 and the distal section 1, the catheter 151is also provided with a connector 152. Together the two sections and theconnector forms the conduit 153 extending axially along the axis A-A.

The proximal section is formed of a proximal catheter tube 154, defininga first duct 155, and a first sleeve 156 having a base 157, a shaft 158,a head 159 and a second duct 160 extending there through. The firsttransition end 164 and the proximal end 165 define the axial extent ofthe proximal section.

The head and the shaft of the first sleeve are inserted into the firstduct of the proximal catheter tube and thereby form the proximalsection. In this configuration the first duct and the second ducttogether defines a proximal part of the conduit. To avoid separation theproximal catheter tube and the first sleeve are welded together. Othermeans for joining exists, such as gluing. Additionally or alternativelythe outer circumference of the shaft and the head of the first sleevemay be larger than the inner circumference of the proximal catheter tubewhereby the tube will grip tightly around the first sleeve.

As can be seen the first proximal section have an outer surface with afirst surface portion 181 with a first circumference, which when seen inthe longitudinal direction is followed by a second surface 182 having asecond circumference which is larger than the first circumference. Athird surface portion 183 follows the second surface portion. The thirdcircumference of the third surface portion is smaller than the secondsurface portion. By providing smooth transitions between the first,second and third surface portion a bulb 161 is provided on the outersurface of the proximal catheter tube. In practice the bulb 161 isprovided by the head 159, which is formed with an enlarged surfaceportion, which has a larger circumference than the shaft 158. The headwill thereby radially expand the proximal catheter tube and create thebulb 161.

By forming a fourth surface portion 184 on the base 157 with acircumference which is larger than the circumference of the thirdsurface portion, a first rim 162 is provided when the proximal cathetertube and the first sleeve are joined to form the proximal section. Aslot 163 is thereby formed between the second surface portion, i.e. thebulb 161, and the fourth surface portion, i.e. the first rim 162.

The distal section 1 is formed of a distal catheter tube 180, defining athird duct 165 and a second sleeve 166 having an outer tapering surface167, an incision 168 and a fourth duct 169. A second transition end 170and a distal end 171 define the axial extent of the proximal section.

The circumference of the fourth duct of the second sleeve is smallerthan the circumference of the third duct of the distal catheter tube.When they are joined this relation provides a second rim 172. A key 173,provided by a fifth surface portion 185, is thus defined between thesecond rim and the second transition end 170.

In order to provide as smooth transition to from the proximal section tothe distal section when the catheter is in its expanded configurationthe outer surface of the second sleeve has an eighth surface portionshown as the outer tapering surface 167, which decreases towards thesecond transition end.

The distal catheter tube 180 and the second sleeve 166 are joinedtogether by inserting the incision into the third duct. The area of thedistal catheter tube contacting a ninth surface portion 187 of theincision thereto is then welded together to fix the distal catheter tubeand the second sleeve to each other. In this configuration the thirdduct and fourth duct together forms the distal part of the conduit.

When the catheter is moved from its collapsed configuration, as shown inFIG. 16, to its expanded configuration, as shown in FIG. 17, the key 173engages with the slot 163 and thereby couples the proximal section andthe distal together in the expanded configuration.

The illustrated catheter assembly is especially advantageous for usewith expandable catheters having a hydrophilic coating (not shown). Ascan especially be seen in FIGS. 20 and 21 a gap 175 is provided betweenthe surface of the key and the surface of the slot. A gap ofapproximately the same size is furthermore provided when the key isdisplaced along the first surface portion 181 of the proximal section onthe other side of the bulb 161 from the slot. The gap provides radialclearance between the key and the first surface portion which avoidsthat the hydrophilic coating is scraped off the proximal section whenthe sections are axially displaced. Furthermore, the hydrophilic coatingwill fill out the gap and the surface tension of the hydrophilic coatingwill advantageously center the key evenly around the first surfaceportion.

As can be seen the axial extent of the key is slightly longer than theextent of the slot. This will jam the key between the first rim and thesloping surface 174 of the bulb 161. Advantageously this will seal offthe gap whereby the mucosa of the urethra, which is very flexible, i.e.the mucosa follows the curvature of the urinary catheter, may beprevented to enter the gap wherein the mucosa otherwise could get caughtbetween the key and slot and consequently get squeezed causing pain andmaybe even tear the mucosa.

As the circumference of the key 173 limits the outer circumference ofthe proximal catheter tube the key typically only extends a fewmillimeters. Thus, to provide secure engagement of the proximal anddistal section and to avoid that they unintentionally are pulled apartit is desirable that the first rim 162 and the second rim 172 contactseach other in a large surface area. Furthermore it is desirable that theedges of the first and second rim and are well defined, and preferablyhas a small rounding in order to prevent that the rounding surface mayact as guides which may push the rims key over the fourth surfaceportion 184.

In order to properly seal the gap the second transition end 170, whichabuts against the bulb 161 is exerting an axially directed force F₁ ontothe distal sloping surface 174 of the bulb. For secure seal the slopingsurface will react with an equally opposite axially directed force F₂.However should the size of the force F₁ become too large the bulb willcollapse, which will result in that the distal and proximal section willbe uncoupled and the catheter will move from its expandableconfiguration to its collapsed configuration.

In order to prevent this the distance between the radial extendingdistance from the surface 177 of the slot to the maximal radialextending distance of the bulb, a, should be at least two times thelength than the radial extending distance from the surface of the slotto the surface of the key, b, i.e. a≧2*b. The distance b corresponds tothe size of the gap 175 seen transverse to the longitudinal direction.It should however be understood that this relation may vary depending onthe material of respectively the key and the bulb and the type ofcoating used to coat the catheter.

Furthermore, the angular slope of the distal sloping surface 174 to theaxis A-A will affect the required size of F₁ in order for the sectionsto uncouple and the chance that the mucosa may get squeezed between thesecond transition end and the sloping surface. Furthermore suchrelations will also depend on the types of materials used.

One type of materials used to produce the catheter may be rigidpolyurethane, such as Estane ETE X1014 for the distal section 1 and thefirst sleeve 156. The proximal catheter tube 154 may for example beformed of soft polyurethane, such as Estane 58212.

When used the expandable catheter is moved from its collapsedconfiguration into its expanded configuration. The proximal end 165 isinserted into the urethra followed by the proximal section 2 and thedistal section 3 until urine start flowing through the conduit.

The catheter is usually inserted by into the urethra by gripping theconnector part 152 between two or more fingers of one hand and guidingthe proximal end into the urethra with the other hand. The urine willflow through the through a hole 178 formed in the proximal section 2close to the proximal end, into the conduit and then through the conduitin mainly a longitudinal direction parallel to the longitudinal extent,shown as axis A-A in FIGS. 17-19 b, of the conduit, as indicated by thearrow 179 in FIGS. 15 and 16, and out through the connector 152.

Although the embodiment illustrated in FIGS. 15 a-18 is especiallysuited for hydrophilic-coated catheters it may be used for other typesof coated catheters known to the skilled person, for example gel coatedcatheters.

FIG. 22 illustrates another embodiment of the coupling structures of acatheter 200 according to invention. The figure shows seen inlongitudinal section the area of the catheter in where the proximalsection 2 and the distal section 1 couples together in the cathetersexpanded configuration.

The proximal section is formed of a proximal catheter tube 201 whereinthe neck 202 of a sleeve 203 is inserted. In order to fix the two partstogether a weld has been provided between the neck and the inner surfaceof the proximal catheter tube. A first transition end 204 is defined atthe distal end of the sleeve 203

The distal section is formed of a one-piece molded catheter tube 205.The distal section have a first outer surface portion 206 having anincreasing circumference seen from a second transition end in thelongitudinal direction towards a distal end (not shown). The innersurface of the distal section is, seen in order from the secondtransition end, provided with a first 208, second 209, third 210 andfourth 211 surface portions. The first and third surface portions have asmaller circumference than the second and fourth surface portion. As canbe seen in FIG. 22 the second surface portion thus forms a slot 216defined by the first and third surface portion.

Corresponding to the inner surface portions of the distal section thereis provided a fifth 212, sixth 213, seventh 214 and eighth 215 surfaceportions on the outer surface of the proximal part. The fifth surfaceportion has a circumference, which is smaller than the circumference ofthe first surface portion, and the seventh surface portion has acircumference, which is smaller than the circumference of the thirdsurface portion. The sixth surface portion has a circumference, which issmaller than the second surface portion but larger than thecircumference of the fifth and seventh surface portion. The eighthsurface portion has a circumference which is smaller than thecircumference of the fourth surface portion but larger than thecircumference of the third surface portion.

The sixth surface portion is advantageously provided as an annularflange being flexible transverse to the axis of the catheter. Thisallows for the flange to function as a key 217, which engages with theslot when the catheter is in its expanded configuration. By beingflexible the key will easily move past the third surface portion.

Furthermore, as the eighth surface portion has a circumference which islarger than the circumference of the third surface portion a stop isprovided as a protruding rim 218, which prevents the distal section andthe proximal section from being pulled apart.

EXAMPLES Example 1 Pull-Out Force Endurance

The test is performed as a tensile test in a standard test machine as aLloyd LR 5K. The desired konical connection is placed in the tensiletest machine and the force is measured when the parts are pulled apart.The maximum load is registered. Materials in the test is Estane ETEX1014 for the outer tube and Estane 58212 for the inner tube (see Table1).

The default configuration takes about 12 N to pull apart (Error!Reference source not found., I, illustrated in Error! Reference sourcenot found.). However, when the thickness of the distal section isdoubled (too 0.7 mm) it takes about 20N to pull the two sections apart(Error! Reference source not found., II, illustrated in FIG. 5 showsanother embodiment 50 of the catheter, which discloses one way to obtaindecreased elasticity in the transition end (the distal end) of theproximal section. Here, the thickness of the end wall of the distalsection 1 has been increased by molding the tube with a thicker wall 52.

). If the thickness of wall of the proximal section is increased to 1.6mm, the force required to pull the two sections apart goes from 12 N toabout 30 N (Error! Reference source not found., III, illustrated in FIG.3 shows the principle of another embodiment of a catheter 30 accordingto the invention. The distal section 1 (the outer section) displays adecreased outer circumference 31 in the transition, whereas the proximalsection 2 (the inner section) displays an increased outer circumference32 in the transition.

The proximal end of the distal section 33 is here cut to allow for asmooth transition point.

By adding cylindrical parts such as the decreased outer circumference 31and the increased outer circumference 32 the surface of the transitionsections is increased, thereby creating a larger area wherein the distalsection and proximal section can couple together.)

).

A synergistic effect was observed when the thickness of both theproximal and the distal transition was increased (doubled as describedabove). Then, a force of about 60 N was required to pull the sectionsapart (Error! Reference source not found., IV, illustrated in FIG. 6shows another embodiment 60 of the catheter, which discloses one way toobtain decreased elasticity in the transition end (the proximal end) ofthe distal section. Here, the thickness of the end wall of the distalsection 1 has been increased by molding the tube with a thicker wall 61on that part.)

).

Example 2 Catheter with Increased Wall Thickness

In this example, sufficient endurance of the transition between theproximal section and the distal section in an expanded catheter isobtained by increasing the wall thickness.

As clearly shown in FIG. 3 shows the principle of another embodiment ofa catheter 30 according to the invention. The distal section 1 (theouter section) displays a decreased outer circumference 31 in thetransition, whereas the proximal section 2 (the inner section) displaysan increased outer circumference 32 in the transition.

The proximal end of the distal section 33 is here cut to allow for asmooth transition point.

By adding cylindrical parts such as the decreased outer circumference 31and the increased outer circumference 32 the surface of the transitionsections is increased, thereby creating a larger area wherein the distalsection and proximal section can couple together.

, a doubling of the wall thickness is obtained by inserting anadditional tube inside the proximal tube (in the distal end, thetransition end).

However, during molding of the catheter tube, the inner-wall can bereinforced by increasing the wall-thickness—such increasedwall-thickness is clearly illustrated in FIG. 4 shows another embodiment40 of the catheter, which discloses one way to obtain decreasedelasticity in the transition end (the distal end) of the proximalsection.

The embodiment of FIG. 4 is identically to the embodiment of FIG. 3,however, the thickness of the wall has been doubled by insertion of anadditional tube 41, which stabilizes the transition and providesdecreased elasticity.

The same principle as described for the inner-wall, can be applied tothe outer-wall (the distal section). As shown in FIG. 5 shows anotherembodiment 50 of the catheter, which discloses one way to obtaindecreased elasticity in the transition end (the distal end) of theproximal section. Here, the thickness of the end wall of the distalsection 1 has been increased by molding the tube with a thicker wall 52.

, the thickness of the wall of the distal section is increased while theinner circumference of the tube is decreased. From the outside itappears as a straight line, giving a smooth feeling to thisreinforcement. When the outer circumference of the proximal section hasreached it's minimum, that is the circumference the rest of the tubehas, the decrease in outer circumference of the distal section starts,ending in a smooth transition.

However, to obtain the highest pull-force, as disclosed in the exampleabove, a combination of decreased elasticity of both the inner- andouter tubes is provided in the transition, only. Such combination isillustrated in FIG. 6 shows another embodiment 60 of the catheter, whichdiscloses one way to obtain decreased elasticity in the transition end(the proximal end) of the distal section. Here, the thickness of the endwall of the distal section 1 has been increased by molding the tube witha thicker wall 61 on that part.

, where the wall thickness of the distal section increases while theinner circumference of the tube decreases. The decrease in innercircumference of this distal section is matched with an increase inouter circumference of the proximal section. However, during thisincrease in outer circumference of the proximal section the innercircumference is kept constant. Hereby, both of the sections comprisesreinforced transition parts.

Example 3 Catheter with Third Element

As illustrated in FIG. 7 shows another embodiment 70 of the catheter,which discloses a combination of FIG. 4 shows another embodiment 40 ofthe catheter, which discloses one way to obtain decreased elasticity inthe transition end (the distal end) of the proximal section.

The embodiment of FIG. 4 is identically to the embodiment of FIG. 3,however, the thickness of the wall has been doubled by insertion of anadditional tube 41, which stabilizes the transition and providesdecreased elasticity.

and FIG. 5 shows another embodiment 50 of the catheter, which disclosesone way to obtain decreased elasticity in the transition end (the distalend) of the proximal section. Here, the thickness of the end wall of thedistal section 1 has been increased by molding the tube with a thickerwall 52.

: an increased wall-thickness in the transition end of both the distalsection and the proximal section.

, the decreased elasticity in the transition can effectively be providedto both sections through a third element. This element will becometrapped between the two sections, and provide the endurance needed. Anexample is a third element made of Estane X4995. In this case, bothsections shall endure full expansion/compression in order to separate.Here, the material is placed between the two sections. However, asillustrated in Error! Reference source not found., this third materialcan be placed on the outside of the tubes as well.

Example 4 Transition Point

It is important to provide a smooth transition point. Especially, theactual point of transition, that is where mucosal exposure to theproximal section stops and mucosal exposure to the section begins. Asillustrated in FIG. 8 shows another embodiment 80 of the catheter, whichdiscloses transition with a third element. That is, the thick black lineis the distal section 81. The outer circumference of the distal sectiondecreases (going from left to right), is followed by a flat segment, andis thereafter pointed to provide for a smooth transition point. Theproximal section 82 is the hatched line. The outer circumference of thisproximal section increases (going from right to left). The two sectionscan be pulled together. However, a third element 83 is positionedbetween the decrease in outer circumference of the distal section andthe increase in outer diameter of the proximal section.

, one such transition can be obtained by cutting the proximal end of thedistal section in a pointed angle. However, as illustrated in Error!Reference source not found., this pointed angle can fit closely to thesegment of the proximal section where the outer diameter is increasing.Obtained hereby is that the outer diameter of the regular tubularsegment of the proximal section is smaller than the inner diameter ofthe proximal end of the distal section. The coating of the catheter isnot damaged during pulling the two sections together during expansion ofthe catheter.

An alternative is illustrated in FIG. 10 illustrates another embodiment100 of the catheter, which discloses the transition between the distalsection 101 (left) and the proximal section 102 (right). The distalsection is cut to be pointed towards the end (the proximal end) and fitstowards the part of the proximal section undergoing an increase in outercircumference. The inner circumference of the tip in the transition endof the distal part is bigger than the outer circumference of theproximal section so that a coating on the proximal section is notdamaged when the tip passes this section during expansion of thecatheter.

FIG. 11 illustrates another embodiment 110 of the catheter, whichdiscloses a bulb 111 on the proximal tube, just proximally to thetransition part.

. Here, a bulb, or a circular protrusion is provided on the proximalsection. This bulb will ‘lift’ the mucosa to avoid contact with thepoint of transition. Furthermore, such bulb will act as a mechanicallock between the distal and the proximal section of the catheterallowing passage in one direction but not in the other.

Example 5 Rigidity of Catheter Parts

The rigidity of a tube is a function of the design (form andcircumference) and material properties such as E-modulus or for verysoft materials the hardness. For a male person it is important that theproximal part of the catheter—the part that when inserted protrudes fromthe bladder to the pelvic floor—is soft and flexible in order to fit thecurvature of the urethra. The rigidity must be low. At the same time theproximal part must have good kinkability.

In the contrary hereto, the distal part should be more rigid to enableeasy insertion by avoiding that the catheter bends before the opening ofthe urethra (meatus). The kinkability of the distal part is typicallynot critical as it can be controlled and monitored by the user.

Estane ETE X1014 is the preferred material for the distal part andEstane 58212 is the preferred material for the proximal part. ETE 60DT3is an example of material for the distal part with the lowest acceptableE-modulus—see Table 1 for data for different materials are mentioned.

A length of 11 cm is cut from the middle of the catheter. The catheteris placed in water at a temperature of 23° C. for 30 sec. The catheteris then placed in an adapter situated on the tensile test machine. Thetensile machine is started and the force to compress the catheter islogged.

FIG. 12 shows the force applied to a typical distal catheter section.The abscissa indicates the compression of the section in millimeters(Extension, mm) and the ordinate indicates the load force applied in N.

As illustrated in FIG. 12, compression of this typical distal sectionwith a high E-modulus results in a linear compression with the forceapplied. However, at a certain point (15 N), the section kinks, and theforce needed for further bending is low.

FIG. 13 shows the force applied to a typical proximal catheter sectionas described. This elastic section will bend almost proportionally withthe force applied. The abscissa indicates the compression of the sectionmillimeters (Extension, mm) and the ordinate indicates the load forceapplied in N.

As illustrated in Error! Reference source not found., compression ofthis typical proximal section with a low E-modulus results in a constantbending of the section with a constant force. The curve in FIG. 13 risessteeply from 0 to 2 N during the first four millimeters of compressionof the proximal catheter section. After the first four millimeters thecurve flattens, indicating that the proximal section has bent as itstill exerts a load of approximately 2 N.

Thus, to provide a distal section and a proximal section so that thefirst longitudinal directed force required for moving the catheter froman expanded position to a collapsed position is larger than the secondlongitudinal directed force required for at least one of the proximalsection and the distal section to bend, the first longitudinal directedforce is chosen to be above 2 N, which is the second longitudinaldirected force. I.e. the coupling structures provided when the catheteris in its expanded configuration needs to be rigid enough to resist aload of at least 2 N. Preferably the coupling configuration isdimensioned so that it may resist even higher loads, such as 3-10 N.

Alternatively, keeping in mind that the push-in force required to insertthe catheter into the urethra is approximately 1 N, the proximal anddistal sections can be provided so that the first longitudinal directedforce required for moving the catheter from an expanded position to acollapsed position is smaller than the second longitudinal directedforce required for at least one of the proximal section and the distalsection to bend, wherein the coupling structures are dimensioned so thatthe first longitudinal force required is between 1 and 2 N, especiallybetween 1.5 N and 2 N and particularly around 1.7 N.

Tables

TABLE 1 Distal 1 Distal 2 Proximal Material, Estane ETE, X1014 ETE,60DT3 58212 E-modulus (/MPa) 1092 173 56 Form Circular Circular CircularOutside diameter  5.1 mm  5.1 mm  4.0 mm Wall thickness 0.35 mm 0.35 mm0.67 mm Rigidity in N 27.6 (avg. of 3) 14.4 (avg. of 3) 1.4 (avg. of 7)(max force). Method CP 3.2.6002 (25.2-29.4) (13.1-15.4) (1.2-1.6)Stiffness ASTM D747 994 Mpa 186 Mpa Hardness Shore D 75 60 42

What is claimed is:
 1. A catheter comprising: a proximal section that isinserted into and telescopically movable relative to a distal section, aproximal end of the proximal section is insertable into a urethra of auser and the distal section provides a discharge conduit for urine;wherein the proximal section includes a rear portion, and an exteriorsurface of the rear portion diverges away from the proximal end toprovide a diverging rear transition section that is wider than theproximal end of the proximal section; wherein the distal sectionincludes a front portion and an interior surface of the front portionconverges to an opening formed in a front transition end, the opening isnarrower than the diverging rear transition section of the proximalsection.
 2. The catheter of claim 1, wherein the proximal sectionincludes a bump formed in a radial direction that is located between thediverging rear transition section and the proximal end, and the openingis narrower than the bump.
 3. The catheter of claim 2, wherein theproximal section is inserted into the distal section in a collapsedconfiguration that locates the bump distal the opening, and the proximalsection is movable to an expanded configuration that locates the bumpproximal of the opening.
 4. The catheter of claim 3, wherein the bumpprevents the proximal section from moving from the expandedconfiguration to the collapsed configuration.
 5. The catheter of claim3, wherein the catheter is configured such that, when in the expandedconfiguration, a longitudinal force of 2 N or more applied to theproximal section toward the distal section deforms the proximal sectionto an unusable state.
 6. The catheter of claim 3, wherein the bumpprovides a coupling in the expanded configuration that resists movementof the proximal section in a distal direction for longitudinal forces ina range from 5-10 N.
 7. The catheter of claim 1, further comprising ahydrophilic coating.
 8. A catheter comprising: a proximal section thatis inserted into a distal section to provide the catheter with acollapsed configuration, a proximal end of the proximal section isinsertable into a urethra of a user and the distal section provides adischarge conduit for urine; wherein the proximal section includes arear portion, and an exterior surface of the rear portion diverges awayfrom the proximal end to provide a diverging rear transition sectionthat is wider than the proximal end of the proximal section; wherein thedistal section includes a front portion and an interior surface of thefront portion converges to an opening formed in a front transition end,the opening is narrower than the diverging rear transition section ofthe proximal section; wherein the proximal section includes an outwardradial bump located between the diverging rear transition section andthe proximal end, and the opening is narrower than the bump; wherein theproximal section is movable from the collapsed configuration to anexpanded configuration that locates the bump proximal of the opening,and the bump and the front transition end form a coupling that deniesmovement of the proximal section back to the collapsed configuration. 9.A catheter movable from a collapsed storage configuration to an expandeduse configuration, the catheter extending axially in a longitudinaldirection from a proximal end to an opposite distal end, the cathetercomprising: a proximal section insertable into a urinary channel, theproximal section extending axially between the proximal end and a distaltransition end that is provided by a sleeve, and a distal section, aportion of which is insertable into the urinary channel, the distalsection movable separately from the proximal section, the distal sectionextending axially between a second transition end and the distal end;wherein the sleeve extends between the distal transition end to a head,with the distal transition end inserted inside the distal section of thecatheter and the head inserted inside the proximal section of thecatheter; wherein the proximal section includes an outward radial bumplocated between the proximal end and the distal transition end of thesleeve.
 10. The catheter of claim 9, wherein the sleeve has a shaftextending between the distal transition end and the head, and the headis an enlarged head having an outer diameter that is larger than anouter diameter of the shaft.
 11. The catheter of claim 10, wherein theenlarged head of the sleeve contacts an inside surface of t the proximalsection of the catheter to support and define the outward radial bump ofthe proximal section.